BEUDAMED
    FDA Enforcement Class II Terminated

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    Recall: Z-2093-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2093-2014
    Event ID
    68701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Salter Labs
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 25, 2014
    Classification Date
    July 22, 2014
    Termination Date
    September 10, 2014
    Address
    2365 Camino Vida, Carlsbad, CA, 92011, United States

    Description

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    Reason

    The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

    Code Info

    Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614

    Distribution

    Worldwide Distribution - US (nationwide) and the countries of Brazil, United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa.

    Quantity

    584 units